Surgical drape with conductor and method of detecting fluid and leaks in thermal treatment system basins

ABSTRACT

A drape according to the present invention includes a sensing device and is disposed over a thermal treatment system having a basin recessed therein. A drape portion is pushed down into, and conforms to, the basin to form a drape receptacle within the basin for collecting a sterile medium. The sensing device includes electrodes that are typically disposed through the drape and sealed via patches on the non-sterile drape surface. The electrodes provide signals indicating the presence of liquid and/or leaks within the drape container to the system to facilitate control of system operation. In addition, a drape utilized for a plural basin thermal treatment system may form a drape receptacle within each basin. Each drape receptacle includes a sensing device to detect the presence of liquid and/or a leak within that drape receptacle and provide signals to the system to facilitate control of system operation.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part of U.S. patentapplication Ser. No. 10/372,674, entitled “Medical Solution ThermalTreatment System and Method of Controlling System Operation inAccordance with Detection of Solution and Leaks in Surgical DrapeContainers” and filed Feb. 25, 2003, which is a continuation-in-part ofU.S. patent application Ser. No. 09/983,021, entitled “Medical SolutionThermal Treatment System and Method of Controlling System Operation inAccordance with Detection of Solution and Leaks in Surgical DrapeContainers” and filed Oct. 22, 2001. In addition, the presentapplication claims priority from U.S. Provisional Patent ApplicationSerial No. 60/467,129, entitled “Surgical Drape with Conductor andMethod of Detecting Fluid and Leaks in Thermal Treatment System Basins”and filed May 2, 2003. The disclosures of the aforementioned patentapplications are incorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION

[0002] 1. Technical Field

[0003] The present invention pertains to surgical drapes. In particular,the present invention pertains to a surgical drape to contain a sterilesurgical solution and facilitate detection of the presence of solutionand/or leaks within a thermal treatment system basin. The surgical drapeis preferably utilized with thermal treatment systems that thermallytreat a sterile surgical liquid, such as the types disclosed in U.S.Pat. No. 4,393,659 (Keyes et al.), U.S. Pat. No. 4,934,152 (Templeton),U.S. Pat. No. 5,163,299 (Faries, Jr. et al.), U.S. Pat. No. 5,331,820(Faries, Jr. et al.), U.S. Pat. No. 5,333,326 (Faries, Jr. et al.), U.S.Pat. No. 5,400,616 (Faries, Jr. et al.), U.S. Pat. No. 5,402,644(Faries, Jr. et al.), U.S. Pat. No. 5,429,801 (Faries Jr. et al.), U.S.Pat. No. 5,457,962 (Faries, Jr. et al.), U.S. Pat. No. 5,502,980(Faries, Jr. et al.), U.S. Pat. No. 5,522,095 (Faries, Jr. et al.), U.S.Pat. No. 5,524,643 (Faries, Jr. et al.), U.S. Pat. No. 5,551,240(Faries, Jr. et al.), U.S. Pat. No. 5,615,423 (Faries, Jr. et al.), U.S.Pat. No. 5,653,938 (Faries, Jr. et al.), U.S. Pat. No. 5,809,788(Faries, Jr. et al.), U.S. Pat. No. 5,816,252 (Faries, Jr. et al.), U.S.Pat. No. 5,857,467 (Faries, Jr. et al.), U.S. Pat. No. 5,862,672(Faries, Jr. et al.), U.S. Pat. No. 5,879,621 (Faries, Jr. et al.), U.S.Pat. No. 5,950,438 (Faries, Jr. et al.), U.S. Pat. No. 6,003,328(Faries, Jr. et al.), U.S. Pat. No. 6,035,855 (Faries, Jr. et al.), U.S.Pat. No. 6,087,636 (Faries, Jr. et al.), U.S. Pat. No. 6,091,058(Faries, Jr. et al.), U.S. Pat. No. 6,255,627 (Faries, Jr. et al.) andU.S. Pat. No. 6,371,121 (Faries, Jr. et al.) and U.S. Patent ApplicationPublication No. 2003/0231990 (Faries, Jr. et al.). The disclosures inthe above-mentioned patents and patent application publication areincorporated herein by reference in their entireties.

[0004] 2. Discussion of the Related Art

[0005] The above-referenced Keyes et al. patent (U.S. Pat. No.4,393,659) discloses a surgical slush producing system having a cabinetwith a heat transfer basin at its top surface. A refrigeration mechanismin the cabinet takes the form of a closed refrigeration loop including:an evaporator in heat exchange relation to the outside surface of theheat transfer basin; a compressor; a condenser; and a refrigerationexpansion control, all located within the cabinet. A separate productbasin is configured to be removably received in the heat transfer basin.Spacers, in the form of short cylindrical stubs or buttons, are arrangedin three groups spaced about the heat transfer basin and projecting intothe heat transfer basin interior to maintain a prescribed space betweenthe two basins. During use, that space contains a thermal transferliquid, such as alcohol or glycol, serving as a thermal transfer mediumbetween the two basins. A sterile drape, impervious to the thermaltransfer medium, is disposed between the product basin exterior and theliquid thermal transfer medium to preserve the sterile nature of theproduct basin. Surgically sterile liquid, such as sodium chloridesolution, is placed in the product basin and congeals on the side ofthat basin when the refrigeration unit is activated. A scraping tool isutilized to remove congealed sterile material from the product basinside to thereby form a slush of desired consistency within the productbasin. Some users of the system employ the scraping tool to chip thesolid pieces from the basin side.

[0006] As noted in the above-referenced Templeton patent (U.S. Pat. No.4,934,152), the Keyes et al. system has a number of disadvantages. Inparticular, the separate product basin must be removed and re-sterilizedafter each use. Additionally, the glycol or other thermal transfermedium is highly flammable or toxic and, in any event, complicates theprocedure. The Templeton patent (U.S. Pat. No. 4,934,152) discloses asolution to these problems by constructing an entirely new apparatuswhereby the product basin is eliminated in favor of a sterile drapeimpervious to the sterile surgical liquid, the drape being made toconform to the basin and directly receive the sterile liquid. Congealedliquid is scraped or chipped from the sides of the conformed drapereceptacle to form the desired surgical slush.

[0007] The Faries, Jr. et al. patent (U.S. Pat. No. 5,163,299) notesthat scraping congealed liquid from the drape is undesirable in view ofthe potential for damage to the drape, resulting in a compromise ofsterile conditions. As a solution to the problem, the Faries, Jr. et al.patent (U.S. Pat. No. 5,163,299) proposes that the drape be lifted orotherwise manipulated by hand to break up the congealed liquid adheringto the drape. Although this hand manipulation is somewhat effective, itis not optimal, and often is inconvenient and constitutes an additionalchore for operating room personnel. Accordingly, several of the Faries,Jr. et al. patents (e.g., U.S. Pat. Nos. 5,331,820; 5,400,616;5,457,962; 5,502,980; 5,653,938; 5,809,788; 5,857,467; 5,950,438;6,003,328; and 6,035,855) resolve the problem of manual drapemanipulation by disclosing various techniques and/or dislodgmentmechanisms to automatically remove the congealed liquid adhering to thedrape without endangering the integrity of the drape.

[0008] The Templeton patent (U.S. Pat. No. 4,934,152) further disclosesan electrical heater disposed at the bottom of the basin to convert thesterile slush to warmed liquid, or to heat additional sterile liquidadded to the basin. Templeton describes the need for such warm sterileliquid as occurring after a surgical procedure is completed tofacilitate raising the body cavity of the surgery patient back to itsnormal temperature by contact with the warmed liquid. However, there area number of instances during a surgical procedure when it is desirableto have simultaneous access to both warmed sterile liquid and sterilesurgical slush. Accordingly, several of the Faries, Jr. et al. patents(e.g., U.S. Pat. Nos. 5,333,326; 5,429,801; 5,522,095; 5,524,643;5,615,423; 5,653,938; 5,816,252; 5,862,672; 5,857,467; 5,879,621;6,091,058; and 6,255,627) disclose a manner in which to simultaneouslyprovide both surgical slush and warmed surgical liquid during a surgicalprocedure by utilizing a machine having plural basins with each basineither producing surgical slush or heating a sterile liquid. Thismachine typically utilizes a single surgical drape that forms a drapereceptacle within each basin to collect sterile slush and heated sterileliquid produced by the machine in the respective basins.

[0009] In addition, several of the drapes and thermal treatment systemsdisclosed in the above-mentioned patents include specialized features toenhance various aspects of thermal treatment system operation. Forexample, some of the specialized features may include: bladder drapes(e.g., as disclosed in U.S. Pat. Nos. 5,809,788; 5,950,438; and6,003,328); drapes having plates or disks (e.g., as disclosed in U.S.Pat. Nos. 5,457,962 and 5,502,980); reinforced drapes (e.g., asdisclosed in U.S. Pat. No. 5,857,467); drape indicators andcorresponding thermal treatment system detection devices to ensuresterility by enabling system operation in response to detecting asterile drape placed on the system (e.g., as disclosed in U.S. Pat. Nos.5,653,938 and 5,879,621); drapes having indicia to direct placement ofthe drapes on thermal treatment systems (e.g., as disclosed in U.S. Pat.No. 5,615,423); surgical drapes constructed of materials having acoefficient of friction in a particular range and/or drapes includingattachment mechanisms such that a drape may withstand being drawn undera dislodgment mechanism (e.g., as disclosed in U.S. Pat. No. 6,035,855);a stand to elevate objects within a heated basin above the basin floor(e.g., as disclosed in U.S. Pat. No. 6,087,636) and/or a heaterconfigured to cover a portion of the basin (e.g., as disclosed in U.S.Pat. Nos. 6,091,058 and 6,255,627) to prevent the drape from overheatingand puncturing when objects are placed within the basin; and remotecontrol of a thermal treatment system (e.g., as disclosed in U.S. Pat.No. 6,371,121).

[0010] However, when insignificant amounts of liquid are present withina thermal treatment system basin, the system heating and coolingmechanisms operate with minimal thermal resistance, thereby enabling themechanisms to become damaged. Further, the drapes employed by the systemmay be damaged by being disposed proximate the heating or coolingmechanism without having the liquid to absorb the thermal energy. Sinceonly sterile drapes are to be used during surgical procedures, a leak ina surgical drape compromises sterility and contaminates the entiresurgical procedure, thereby increasing the risk of injury to a patient.

[0011] The related art has attempted to overcome this problem byemploying sensing devices with surgical drapes. For example, U.S. Pat.No. 5,524,643 (Faries, Jr. et al.) discloses a surgical drape combinedwith a sensor, preferably attached to the drape, to detect the presenceof liquid within a drape container conforming to a heating/coolingthermal treatment system basin. An alternative embodiment employssensors at opposite surfaces of the drape to measure conductance and,thereby, leakage through the drape. A microprocessor of each embodimentreceives a signal representing, for example, an electrical conductancemeasurement and determines the presence of liquid and/or a leak. Ifliquid is not present or a leak is determined to exist, themicroprocessor disables a temperature controller for the basin toprevent damage to the drape and heating and cooling mechanisms.

[0012] U.S. Pat. No. 5,816,252 (Faries, Jr. et al.) discloses a drapefor use with a system for thermally treating a sterile medium. The drapeincludes liquid sensitive material that changes color upon contact withliquid to indicate the presence of a leak. The liquid sensitive materialmay be placed between the drape and a receiving basin or affixed to thedrape in the form of indicia symbolically directing placement of thedrape over the system. The system may include a single basin and be ofthe type that either thermally cools or heats the sterile medium, or thesystem may include a plurality of basins with each basin eitherthermally cooling or heating the sterile medium. The liquid sensitivematerial detects leaks within the drape while assisting the operator inproperly aligning and placing the drape over the system.

[0013] U.S. Pat. No. 6,102,044 (Naidyhorski) discloses an electrodecarrying surgical drape including a polymeric film having opposingsurfaces and an electrode receiving aperture therethrough. An electrodeis disposed through the aperture, while patches sealingly affixelectrode portions to each of the opposing surfaces of the polymericfilm in the vicinity of the aperture to form a reinforced laminatedstructure capable of maintaining the sterility of an established sterilefield.

[0014] The above-described systems can stand some improvement. Inparticular, the Faries, Jr. et al. sensor drape (U.S. Pat. No.5,524,643) employs a plug connector disposed through the drape tofacilitate connections between the drape sensor and the thermaltreatment system, thereby complicating the process of effectivelysealing the drape to prevent contamination of the sterile field.Further, the drape is required to be placed on the system with the plugaligned with a corresponding plug receptacle for system operation,thereby restricting the manners in which the drape may be positioned onthe system to form the drape container. The Faries, Jr. et al. systememploying liquid sensitive material with a drape (U.S. Pat. No.5,816,252) indicates the presence of a leak within the drape container.However, this system relies on operating room personnel to respond tothe leak indication and perform appropriate actions with respect tosystem operation. Thus, the system may continually operate in thepresence of a drape container leak until personnel notice and respond tothe leak indication, thereby increasing the risk of contamination of asurgical procedure and damage to the system heating or cooling mechanismwhen a drape leak occurs. The Naidyhorski drape electrode primarilyserves as a conduit or path through the drape and typically requiresadditional components to perform sensing functions, thereby increasingcosts and complexity of employing that drape with sensing functions.Moreover, the Naidyhorski drape utilizes patches on each of opposingdrape surfaces to sealingly affix the electrode to the drape. Since apatch is employed on the Naidyhorski drape sterile surface to affix theelectrode to that surface, placement of the electrode on the drapesterile surface is limited, thereby restricting drape sensing functionsto particular drape locations. In addition, the patch on the Naidyhorskidrape sterile surface may interfere with the electrode and/orcorresponding sensors on that surface and adversely affect drape sensingor other functions.

OBJECTS AND SUMMARY OF THE INVENTION

[0015] Accordingly, it is an object of the present invention to detectthe presence of solution and/or a leak within a drape container disposedin a thermal treatment system basin and control system operation inaccordance with detected drape container conditions.

[0016] It is another object of the present invention to dispose aconductor or other object through a sterile surgical drape whilemaintaining the sterile field.

[0017] Yet another object of the present invention is to employ asurgical drape including solution and/or leak sensors with a thermaltreatment system including circuitry that interfaces the drape tocontrol system operation in accordance with drape conditions detected bythe sensors and circuitry.

[0018] A further object of the present invention is to dispose aconductor through a sterile surgical drape and seal the electrode anddrape via patches disposed on the non-sterile drape surface.

[0019] The aforesaid objects may be achieved individually and/or incombination, and it is not intended that the present invention beconstrued as requiring two or more of the objects to be combined unlessexpressly required by the claims attached hereto.

[0020] According to the present invention, a drape including a sensingdevice is disposed over a top surface of a thermal treatment systemhaving a basin recessed therein. A portion of the drape is pushed downinto, and conforms to, the basin to form a drape container or receptaclewithin the basin for collecting a sterile medium. The thermal treatmentsystem may be of the type that either heats or congeals the sterilemedium to respectively produce a warm sterile liquid or sterile slushwithin the basin. The sensing device includes electrodes that aretypically disposed through the drape and sealed via patches on thenon-sterile drape surface. The electrodes provide signals indicating thepresence of liquid and/or leaks within the drape container to the systemto facilitate control of system operation. In addition, the sensingdevice may be affixed to a drape utilized for a multiple basin thermaltreatment system wherein each basin may either heat or congeal thesterile medium as described above. The multiple basin drape forms adrape receptacle within each basin, while a sensing device is typicallydisposed within each drape receptacle to detect the presence of liquidand/or a leak within that drape receptacle and provide a signal to thesystem to facilitate control of system operation in substantially thesame manner described above.

[0021] The above and still further objects, features and advantages ofthe present invention will become apparent upon consideration of thefollowing detailed description of specific embodiments thereof,particularly when taken in conjunction with the accompanying drawingswherein like reference numerals in the various figures are utilized todesignate like components.

BRIEF DESCRIPTION OF THE DRAWINGS

[0022]FIG. 1 is a view in perspective of a surgical drape placed over anexemplary thermal treatment system to detect fluid and leaks within athermal treatment system basin according to the present invention.

[0023]FIG. 2 is a view in perspective of the surgical drape of thepresent invention for detecting the presence of fluid and leaks within athermal treatment system basin.

[0024]FIG. 3 is a top view in plan of the sensing device of the drape ofFIG. 2.

[0025]FIG. 4 is a side view in elevation and section of the surgicaldrape of FIG. 2.

[0026]FIG. 5 is block diagram of control circuitry for the system ofFIG. 1.

[0027]FIG. 6 is a schematic block diagram of an exemplary conditioncircuit of the detection circuitry within the control circuitry of FIG.5 for determining the presence of liquid and/or leaks within a drapecontainer.

[0028]FIGS. 7A-7B are detailed electrical schematic diagrams of theexemplary condition circuit of FIG. 6.

[0029]FIG. 8 is an exploded perspective view of a surgical drapeincluding plural sensing devices and disposed over a plural basinthermal treatment system according to the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0030] An exemplary thermal treatment system and drape to heat a sterilemedium (e.g., solution or liquid) and detect drape container conditionsaccording to the present invention is illustrated in FIG. 1.Specifically, the system includes a cabinet or housing 31, a wiringhousing 45 attached to the cabinet and a warming basin 33 recessed intoa cabinet top surface 34. Basin 33 may be of any shape, however, by wayof example only, the basin is illustrated as being substantiallyrectangular. A power switch 37 and a temperature controller/indicator 38are provided on top surface 34 toward the cabinet front wall with thewarming basin residing between the power switch and controller. Wiringhousing 45 is attached to the cabinet side wall that is closest to powerswitch 37 and facilitates connections as described below. A heater 70(FIG. 5) is disposed on the underside and/or sides of the basin to heatthe basin and the sterile medium contained therein. The heater iscontrolled by controller 38 in accordance with an entered desiredtemperature and temperatures measured by a temperature sensor 72 (FIG.5) as described below. Heater 70 is typically implemented by aconventional etched foil silicon rubber heating pad and is attached tothe basin via a pressure sensitive or other type of adhesive. The heatermay alternatively be of any quantity (e.g., at least one), shape orsize, and may include any configuration (e.g., strips, bars, segments,etc.) that covers the entirety or any portion of the basin. In addition,the heater may be implemented by any conventional or other type ofheater or heating element (e.g., heating coils, etc.) that may bedisposed on the basin at any suitable locations.

[0031] Temperature sensor 72 is preferably implemented by a conventionalresistive temperature device (RTD) (e.g., a 1,000 Ohm RTD). However, thesensor may be implemented by any conventional or other type oftemperature sensor, and may be disposed at any suitable location on thebasin or within the cabinet. It is to be understood that the thermaltreatment system described above may have various configurations. Forexample, the thermal treatment system may be configured to cool and/orcongeal the medium to produce cooled liquid or surgical slush. In thisinstance, the heater may be replaced by refrigeration devices that arecontrolled in substantially the same manner described below in responseto detection of solution and leaks within the drape container. Further,the thermal treatment system may include a plurality of basins warmingand/or cooling a sterile medium. Examples of warming, cooling and/orplural basin systems are disclosed in several of the above-mentionedFaries, Jr. et al. patents (e.g., U.S. Pat. Nos. 5,333,326; 5,429,801;5,522,095; 5,524,643; 5,615,423; 5,653,938; 5,816,252; 5,862,672;5,857,467; 5,879,621; 6,091,058; and 6,255,627).

[0032] A sterile drape 17, preferably transparent, is typically disposedover the top and sides of cabinet 31 and made to conform to the sidewall and bottom of basin 33. Power switch 37 and controller 38 aredisposed on top surface 34 of system cabinet 31 and are adjustablemanually through drape 17. The portion of drape 17 disposed in basin 33serves as a sterile container or receptacle for sterile liquid placedtherein to be heated. Typical sterile liquid treated by the thermaltreatment system is a 0.80% to 0.95% sodium chloride solution (i.e.,saline). Drape 17 is made from materials that are impervious to thesterile liquid and sufficiently soft and flexible to conform to a basinwall. The thickness of the drape is preferably minimized to renderthermal transfer therethrough most efficient, yet the thickness issufficient to resist tearing and puncturing during normal use. The drapemay be made of materials commonly used in hospitals for surgical drapes,or may be made of polyurethane film as disclosed for the drape in U.S.Pat. No. 4,934,152 (Templeton). The drape may further include apreformed container portion contoured to match the contour of a basin.The preformed container portion may be (but is not necessarily) thickerthan the remaining portions of the drape described above in order toresist puncture and enable the container portion to maintain the shapeof the basin. By way of example only, the container portion may be madeof a heavy gauge polyethylene/ionomer resin blend. The percentage ofionomer resin in the blend is typically (but not necessarily) in theapproximate range of forty to seventy percent. The drape is designed tobe disposable after a single use to enhance patient safety and isprovided presterilized and prepackaged in a manner to preserve itssterile state during storage.

[0033] The drape is typically positioned over the thermal treatmentsystem with a portion of the drape disposed in a basin to form a drapereceptacle as described above. The drape forms a sterile field above thebasin to maintain sterility of the sterile medium. However, a puncture,tear or other opening in the drape disrupts the sterile field and maycontaminate the sterile liquid, thereby risking injury to a patient.Further, the thermal treatment system may damage the drape (e.g., viathe heating or refrigeration device) in the event that liquid is notpresent within the drape container.

[0034] In order to detect the presence of liquid and/or leaks within thedrape container to maintain drape integrity and sterility of the sterilemedium, drape 17 includes a sensing device as illustrated in FIGS. 2-3.Specifically, drape 17 is substantially rectangular and includes asensing device 90 to detect the presence of liquid and leaks within adrape container. Sensing device 90 is in the form of a pair ofelectrodes 92, 94 that are affixed to a generally rectangular strip 95disposed on an intermediate portion of the drape sterile surface. Theelectrodes are disposed on the electrode strip toward respective striplonger dimensioned edges and extend substantially in parallel. Theelectrode strip is enclosed within a pouch 96 to secure the electrodesto the drape and to protect the electrodes from sharp objects that maybe disposed within the basin. In addition, the pouch assists to preventgrounding of the electrodes or formation of a current flow paththerebetween due to placement of conductive objects (e.g., instruments,stainless steel pitchers, etc.) in the basin that may produce erroneousdetections. The pouch is preferably formed from a substantiallyrectangular segment or flap 98 that is attached (e.g., welded) to thedrape sterile surface and sealed by seams 93, each formed toward andextending along a respective flap longer dimensioned edge.

[0035] The distal ends of the electrodes are attached to a plug orconnector 91 that interfaces detection circuitry within the thermaltreatment system as described below. The plug includes electrode tracesdisposed on a plug top surface. The distal portions of strip 95 andelectrodes 92, 94 pass through the drape from the sterile to thenon-sterile drape sides via an opening or slit 97 defined in the drapeat an intermediate location. Substantially circular segments or patches99, 101 are attached to the non-sterile drape surface and to each otherto seal opening 97 and strip 95. The patches are each basically in afolded configuration to encompass and seal the opening and strip inorder to prevent escape of liquid from, and maintain sterility of, thedrape container as described below.

[0036] Referring to FIG. 4, patches 99, 101 are each attached to thedrape non-sterile surface on respective opposing sides of opening 97.Patch 99 includes a drape engagement section 102, a fold or bend 104disposed at an intermediate patch location and a transverse section 106extending transversely relative to drape 17 from fold 104. Drapeengagement section 102 of patch 99 is attached to the non-sterile drapesurface coincident pouch 96 with fold 104 disposed proximate opening 97.Patch 99 may be attached to the drape via any conventional or othertechniques (e.g., heat welding, pressure, etc.). Transverse section 106extends in a transverse direction relative to the drape from fold 104and along the bottom surface of strip 95 extending through opening 97.

[0037] Patch 101 is substantially similar to patch 99 and includes adrape engagement section 103, a fold or bend 105 disposed at anintermediate patch location and a transverse section 107 extendingtransversely relative to drape 17 from fold 105. Drape engagementsection 103 of patch 101 is attached to the drape non-sterile surface onthe side of opening 97 opposing patch 99. Patch 101 may be attached tothe drape via any conventional or other techniques (e.g., heat welding,pressure, etc.). Fold 105 is disposed proximate opening 97 withtransverse section 107 extending in a direction transverse to the drapefrom the fold along the top surface of strip 95. The electrode strip isbasically disposed between the transverse sections of patches 99, 101,where the transverse patch sections are fused or attached to each otherand/or the drape non-sterile surface to effectively seal opening 97 anda portion of strip 95. The strip extends beyond the sealed patches forconnection to the detection circuitry as described below. Flap 98 andpatches 99, 101 are preferably constructed of drape materials, however,the flap and patches may be constructed of any suitable materials, maybe of any shape or size, and may be disposed on the drape at anysuitable locations via any conventional or other techniques.

[0038] Referring back to FIGS. 1-3, sensing device 90 detects thepresence of liquid and leaks within the drape container in response toplacement of drape 17 over the thermal treatment system. In particular,current flow between the electrodes is initiated in response to theelectrodes contacting liquid. The current flow causes a respectivechange in voltage that indicates a condition and is detected bydetection circuitry within the thermal treatment system as describedbelow. In order to enable the liquid in the drape container to contactthe electrodes and facilitate current flow between those electrodes,flap 98 includes a series of slots 83. The slots are defined in the flapbetween seams 93 and are spaced from each other in a direction of theflap longer dimension. The slots are generally rectangular and extendsubstantially perpendicular to electrodes 92, 94. Each slot includes alonger dimension substantially similar to the width of strip 95 andencompasses portions of each electrode 92, 94 to facilitate enhancedexposure of the electrodes to liquid within the drape container.Alternatively, flap 98 may include a series of substantially circularopenings (not shown) defined therein to permit contact between theliquid and electrodes. Flap 98 may include any quantity of slots oropenings of any shape or size and disposed at any locations in anydesired fashion to facilitate contact between the electrodes and liquidwithin the drape container.

[0039] Current flow between the electrodes is initiated in response tothe electrodes contacting liquid, where the current flow causes arespective change in voltage that indicates the presence of solutionwithin the drape container. Further, the presence of a leak within thedrape container enables current to flow between the electrodes andground (e.g., the basin beneath the drape). The detection circuitrywithin the thermal treatment system measures the voltage of and betweenthe electrodes to determine drape container conditions. In particular,the detection circuitry initially applies a reference voltage orpotential to electrodes 92 and/or 94. Since the electrodes areelectrically isolated from each other within strip 95 as describedabove, current flow between the electrodes is prevented and thepotential of and between those electrodes basically remains unchanged.

[0040] When the sterile medium is placed in the drape container, thesterile medium contacts electrodes 92, 94, thereby forming an electricalpath or conductive bridge between those electrodes. Accordingly, currentflow between the electrodes is initiated in response to the electrodescontacting liquid, thereby causing a change in the potential of andbetween electrodes 92, 94. Further, the presence of a leak within thedrape container enables current to flow between the electrodes andground (e.g., the basin beneath the drape), thereby causing a furtherchange in the potential of and between electrodes 92, 94. The currentflow (or lack thereof) resulting from each of the above conditions isdetected by the detection circuitry within the thermal treatment system.This is typically accomplished by detecting the potential or voltage ofand between electrodes 92, 94. The magnitude of the voltage or voltagechange is utilized by the detection circuitry to detect the presence ofsolution and/or leaks within the drape container and to control systemoperation in accordance with the detected conditions as described below.For example, the detection circuitry may disable the thermal treatmentsystem in response to the absence of liquid or the presence of a leakwithin the drape container.

[0041] Wiring housing 45 (FIG. 1) receives signals from electrodes 92,94 (e.g., plug or connector 91 may be received in a wiring housingreceptacle 49) and includes wiring to transfer signals between thathousing and detection circuitry 100 (FIG. 5) to facilitate detection ofliquid and/or leaks within the drape container. Wiring housing 45 is inthe form of a generally rectangular box and is mounted on a cabinet sidewall toward the cabinet rear portion. The wiring housing includesreceptacle 49 for receiving connector 91 and indicators 41, preferablyin the form of light emitting diodes 147, 149 and 151 to indicate drapecontainer conditions. By way of example only, the wiring housingincludes: green diode 147 to indicate operation of the system (e.g.,solution present without a drape container leak); yellow diode 149 toindicate the absence of solution and leaks within the drape container;and red diode 151 to indicate the presence of a leak within the drapecontainer. The wiring housing may alternatively be disposed at anylocation on cabinet 31 (e.g., top surface, side walls, cabinet interior,etc.), while the receptacle may be disposed at any location on thecabinet or wiring housing.

[0042] The detection circuitry basically prevents system operation(e.g., disables controller 38) in response to a leak or the absence ofliquid within the drape container, or in response to the absence of aconnection between the drape and the thermal treatment system. In otherwords, the detection circuitry determines the drape container or otherconditions based on the electrode signals and controls system operationaccordingly. In addition, the detection circuitry may selectivelyilluminate the diodes to indicate the particular determined drapecontainer conditions (e.g., no fluid, the presence of a leak, etc.). Thewiring housing receives connector 91 within receptacle 49 andfacilitates connections via appropriate wiring between the receptacle,diodes and a circuit board 52 (FIG. 5) of the detection circuitrycontaining a condition circuit 53 (FIG. 6) as described below. Fuses maybe employed to protect the system circuitry from power surges and/orspikes that may cause damage to the system. The wiring connectionsbetween the receptacle, diodes, fuses and/or circuit board may besubstantially similar to those described in the aforementioned patentapplications.

[0043] Referring to FIGS. 1 and 5, cabinet 31 houses control circuitryincluding power switch 37, temperature controller 38, receptacle 49, apower supply 54 and detection circuitry 100. Power supply 54 providesappropriate power signals to the control circuitry components andincludes a receptacle to receive signals from a power cord interfacing aconventional wall outlet jack. The power switch enables power to thecircuitry components and may be implemented by any conventional or otherswitching device. Plug or connector 91 is received in receptacle 49 toprovide signals from the electrodes to the detection circuitry. Thisfurther enables the detection circuitry to detect the presence of adrape on the system as described above. The temperature controllercontrols the heater, while the detection circuitry determines the drapecontainer conditions based on the electrode signals and controls thetemperature controller accordingly. The wiring housing may include audioand/or visual indicators 41 (e.g., beeper or buzzer, speaker 197 (FIG.6), various colored light emitting diodes (e.g., green diode 147, yellowdiode 149 and red diode 151), etc.) to indicate drape containerconditions as described above. The detection circuitry may selectivelyactuate the indicators in any fashion to indicate the particulardetermined drape container conditions (e.g., absence of the drape orsolution, the presence of a leak, etc.). The control circuitrycomponents may be disposed on and/or within the cabinet and/or wiringhousing in any fashion at any desired locations.

[0044] Temperature controller 38 is connected to heater 70 andtemperature sensor 72 to control the heater in response to a desired orset point temperature entered by a user and the temperature measured bythe temperature sensor. In particular, temperature controller 38 istypically implemented by a conventional temperature controller ormicroprocessor and includes a display 47 and input devices 43 (e.g.,buttons, keys, etc.). The temperature controller controls power to theheater based on a comparison of the temperature measured by temperaturesensor 72 and the set point temperature entered by the user via inputdevices 43. The temperature controller may further display the measuredand/or set point temperatures or any other desired information ondisplay 47. The information to display may be selected by a user viainput devices 43. When the measured temperature exceeds the set pointtemperature, controller 38 disables or reduces power to the heater.Conversely, when the measured temperature is below the set pointtemperature, controller 38 enables or increases power to the heater. Athermostat 68 may be disposed between the controller and heater todisable current to heater 70 in response to a temperature measurementexceeding a temperature threshold. The thermostat disables the heater inresponse to detection of excessive heater temperatures and may beimplemented by any conventional switching type or limiting devices, suchas a high limit thermostat, and disposed at any suitable location.

[0045] Temperature controller 38 further controls heater 70 in responseto signals received from detection circuitry 100. The detectioncircuitry detects the presence of solution and leaks within the drapecontainer and provides appropriate signals to temperature controller 38.The detection circuitry basically disables the temperature controller(and heater) in response to absence of the drape, absence of solutionwithin the drape container and/or the presence of a drape container leakas indicated by the electrode signals. The detection circuitry may besubstantially similar to the detection circuitry disclosed in theaforementioned patent applications. Alternatively, the detectioncircuitry may include a microprocessor to process electrode signals andcontrol the indicators, heater or any other devices. In this case,electrode signals are converted to digital signals and compared by themicroprocessor to threshold levels for each condition. Themicroprocessor may generate the appropriate control signals to controlbasin thermal devices and various indicators in accordance with thedetermined conditions. The microprocessor may be implemented by orimplement the temperature controller and/or processor 110 describedbelow.

[0046] Exemplary detection circuitry for the system includes circuitboard 52 including condition circuit 53 and green, yellow and red diodes147, 149, 151 indicating the drape container conditions. The circuitboard further includes a series of pins or terminals 1-12 to facilitateconnections and a plurality of indicator lights 79. By way of exampleonly, pins 1 and 2 are connected to wiring housing receptacle orconnector 49 to receive electrode signals, while pins 9 and 11 areconnected to the positive and reference terminals of power supply 54,respectively. Pins 6-8 are connected to pin 9 and provide a voltage(e.g., +12V DC) to the condition circuit, while pin 12 is connected topin 11 and provides a ground. Green diode 147 is connected between pins3 and 6 and is illuminated in response to detection of solution withinthe drape container without a leak, while yellow diode 149 is connectedbetween pins 4 and 7 and is illuminated in response to detection of theabsence of solution and a leak within the drape container. Red diode 151is connected between pins 5 and 8 and is illuminated in response todetection of a leak within the drape container. Pin 10 is basicallyinoperable and utilized to facilitate compatible connections with theboard.

[0047] An exemplary condition circuit 53 for detecting the presence ofsolution and leaks within the drape container is illustrated in FIGS. 6,7A and 7B. Initially, the condition circuit prevents operation of thethermal treatment system in the event a drape is damaged (e.g., containsa leak) or not connected to the detection circuitry, or in the eventsolution is absent from the drape container. The condition circuit iscoupled to the drape electrodes via pins 1 and 2 of circuit board 52.The presence of solution within the drape container causes current flowbetween the electrodes, while a leak facilitates current flow betweenthe electrodes and ground as described above. Accordingly, the currentflow causes a voltage change at pins 1 and 2 of the circuit board,thereby enabling detection of solution and leaks by the conditioncircuit. In particular, the condition circuit includes comparators 184,186, logic circuitry 188, 190, inverters 192, 194, a power switch 196and an oscillator 198. Pin 1 of circuit board 52 is connected to thenon-inverting input of comparator 184, while that input is furtherconnected to a resistor 191 (e.g., 180K Ohm) disposed in series with asupply voltage (e.g., 12V DC). The non-inverting input of comparator 184is further coupled to additional circuitry (FIG. 7B) (e.g., a resistor117 (e.g., 6.8K Ohm) connected in series with pin 1, a resistor 108(e.g., 10K Ohm) coupled to resistor 191 and the supply voltage, a diode115 connected in parallel with resistor 191, a capacitor 111 (e.g., 1.5μf) connected in parallel with resistor 191 and diode 115, and a diode109 connected between the input and a ground potential) to protect thecircuit from damage in the event an external voltage is applied to pins1 and 2 and to provide filtering to prevent a response to noise. A diode195 is disposed in a feedback path of comparator 184 to maintain thestate of a particular condition as described below. The inverting inputof comparator 184 is similarly coupled to additional circuitry (FIG. 7B)(e.g., a resistor 112 (e.g., 6.8K Ohm) connected between resistor 108and a ground potential, and a capacitor 114 (e.g., 0.1 μf) connected inparallel with resistor 112) to enhance circuit performance. Resistors108 and 112 basically provide the comparator inverting input with areference voltage (e.g., 5V DC). Comparator 184 determines the presenceof a drape container leak by comparing the input of pin 1 to thereference voltage (e.g., 5V DC). If pin 1 exceeds the reference voltage,the comparator provides a high level logic signal indicating the absenceof a leak (e.g., the signal LEAK in the figures indicates the absence ofa drape container leak when attaining a high logic level); otherwise alow level logic signal indicating the presence of a leak is produced bythe comparator.

[0048] Pin 2 is connected to the inverting input of comparator 186,while that input is further connected to a resistor 193 (e.g., 270K Ohm)disposed between the comparator input and a ground potential. Theinverting input is further coupled to additional circuitry (FIG. 7A)(e.g., a resistor 124 (e.g., 6.8K Ohm) connected in series with pin 2, adiode 116 connected in series with a supply voltage (e.g., 12V DC), adiode 118 connected in parallel with resistor 193, and a capacitor 122(e.g., 0.68 μf) connected in parallel with resistor 193 and diode 118)to protect the circuit from damage in the event an external voltage isapplied to pins 1 and 2 and to provide filtering to prevent a responseto noise. The non-inverting input of comparator 186 is coupled toadditional circuitry (FIG. 7A) (e.g., a resistor 126 (e.g., 270K Ohm)connected in a comparator feedback path, a resistor 128 (e.g., 27K Ohm)connected between the non-inverting input and a supply voltage (e.g.,12V DC), a resistor 130 (e.g., 6.8K Ohm) connected between thenon-inverting input and a ground potential, and a resistor 132 (e.g.,10K Ohm) connected between a supply voltage (e.g., 12V DC) and thecomparator output) that basically provides a reference voltage (e.g.,2.5V DC) for the comparator non-inverting input. Comparator 186determines the presence of solution within the drape container bycomparing the input of pin 2 with the reference voltage. If thereference voltage (e.g., 2.5V) exceeds pin 2, the comparator produces ahigh level logic signal indicating the absence of solution within thedrape container (e.g., the signal {overscore (SOL)} in the figuresindicates the absence of solution within the drape container whenattaining a high logic level); otherwise a low level logic signalindicating the presence of solution is produced.

[0049] The output of comparator 184 is coupled to inverter 194, to aninput of logic circuitry 188 and to an input of logic circuitry 190. Thecomparator output is further coupled to additional circuitry (FIG. 7B)(e.g., a resistor 134 (e.g., 10K Ohm) connected between the comparatoroutput and a supply voltage (e.g., 12V DC)) to enhance circuitperformance. Inverter 194 is in the form of a NAND gate (FIG. 7B) andinverts the comparator output. Since comparator 184 provides a low levellogic signal in response to the presence of a leak as described above,inverter 194 inverts the comparator output to provide a high level logicsignal in response to a leak (e.g., the signal LEAK in the figuresindicates the presence of a drape container leak when attaining a highlogic level). The inverter is connected to a timer 198 that serves as alow frequency oscillator and is actuated by the high level logic signalproduced by inverter 194 in response to the presence of a leak.Additional circuitry (FIG. 7B) (e.g., a resistor 136 (e.g., 1.5M Ohm)connected in series with the NAND gate output, a resistor 138 (e.g.,270K Ohm) connected between timer inputs, a capacitor 140 (e.g., 1.5 μf)connected between resistor 138 and a ground potential, and a capacitor142 (e.g., 0.1 μf) connected between a timer input and the groundpotential) is connected to and/or between the inverter and oscillator toenhance actuation of the oscillator in response to a high level logicsignal from the inverter. The oscillator output is coupled to areference terminal of a speaker 197 and to pin 5 for actuating red diode151. A resistor 143 (e.g., 1K Ohm) is disposed between pin 5 and theoscillator output, while a speaker positive terminal is connected to asupply voltage (e.g., 12V DC). The oscillator output is in the form of apulse train that provides periodic low level logic signals. The lowlevel signals provide a sufficient voltage differential to enable thesupply voltages of the red diode (e.g., 12V DC of pin 8) and speaker(e.g., 12V DC of the speaker positive terminal) to drive those devices.Thus, the oscillator produces a pulse train that enables the diode toflash and the speaker to beep at rates proportional to the pulse trainfrequency when a leak is present in the drape container.

[0050] Conversely, when a leak is absent from the drape container,comparator 184 provides a high level logic signal as described above.Inverter 194 inverts the comparator output to provide a low level logicsignal in response to the absence of a leak. The low level logic signalis insufficient to actuate oscillator 198, thereby disabling red diode151 and speaker 197 when a leak is not present within the drapecontainer.

[0051] Logic circuitry 188 determines the presence of conditions toenable the heater (e.g., solution is present within the drape containerwithout a leak). The logic circuitry is coupled to outputs ofcomparators 184 and 186. An inverter 192 in the form of a NAND gate(FIG. 7A) is disposed between logic circuitry 188 and comparator 186 toinvert the comparator output. Since comparator 186 produces a low levellogic signal in response to the presence of solution within the drapecontainer as described above, inverter 192 inverts the comparator outputto provide a high level logic signal in response to the presence ofsolution (e.g., the signal SOL within the figures indicates the presenceof solution within the drape container when attaining a high logiclevel). Logic circuitry 188 combines the signals (e.g., {overscore(LEAK)}, SOL) from comparator 184 and inverter 192, indicating leak andsolution conditions, and provides a signal to illuminate green diode 147and actuate power switch circuitry 196 to enable heater 70 in responseto the signals indicating the presence of solution without a leak in thedrape container.

[0052] Logic circuitry 188 (FIG. 7A) includes a NAND gate 144 and acomparator 146. The NAND gate receives output signals from comparator184 and inverter 192 and produces a low level logic signal in responseto the signals indicating the presence of solution in the drapecontainer without a leak. The NAND gate output is connected to thenon-inverting input of comparator 146, while the comparator invertinginput is connected to a reference voltage (e.g., 5V DC). The comparatorproduces a low level logic signal in response to a low NAND gate outputin order to drive power switch circuitry 196 to enable heater 70 whensolution is present within the drape container without a leak. NAND gate144 is further coupled to additional circuitry (e.g., a ground potentialcoupled to a gate terminal, a supply voltage (e.g., 12V DC) coupled toanother gate terminal with a capacitor 148 (e.g., 0.1 μf) connectedbetween that gate terminal and a ground potential) to enhance gateoperation.

[0053] Power switch circuitry 196 includes an optocoupler 150 and atriac 154. The triac is connected between conductors 160, 162 thatprovide signals to temperature controller 38, and has a gate terminalcoupled to an output of the optocoupler. An optocoupler input is coupledto circuit board pin 3 and, hence, to green diode 147 disposed betweencircuit board pins 3 and 6, while a resistor 158 (e.g., 1K Ohm) isconnected between pin 3 and the optocoupler. The output of comparator146 indicating drape container conditions is connected to another inputof the optocoupler to drive the power switch circuitry in response tothe presence of solution without a leak in the drape container asdescribed above. A resistor 152 (e.g., 22 Ohms) is connected to anoptocoupler output and in series with the triac, while a resistor 156(e.g., 1 K Ohm) is connected between the triac gate terminal andconductor 162. A low level logic signal produced by comparator 146provides a ground that enables the optocoupler input to receiveappropriate current to produce outputs that drive the triac. Thus, thelow level logic signal from comparator 146 enables actuation of thegreen diode and triac to indicate the presence of solution without aleak in the drape container and to enable the heater, respectively. Thetriac provides signals to temperature controller 38 to control actuationof the heater as described above.

[0054] Conversely, when a leak is present within, or solution is absentfrom, the drape container, comparators 184, 186 provide signals thatenable NAND gate 144 to produce a high level logic signal. Comparator146 generates a high level logic signal in response to the high levelNAND gate output, thereby preventing actuation of power switch 196,green diode 147 and heater 70 when a leak is present within, or solutionis absent from, the drape container.

[0055] Logic circuitry 190 determines the presence of conditions toilluminate yellow diode 149 (e.g., neither solution nor a leak ispresent within the drape container). The logic circuitry is coupled tothe outputs of comparators 184 and 186. Logic circuitry 190 combines thesignals (e.g., {overscore (LEAK)}, {overscore (SOL)}) from comparators184, 186 indicating drape container conditions and provides a signal toactuate yellow diode 149 in response to the comparator signalsindicating the absence of solution and a leak within the drapecontainer.

[0056] Logic circuitry 190 (FIG. 7A) includes a NAND gate 164 and acomparator 166. The NAND gate receives output signals from comparators184 and 186 and produces a low level logic signal in response to thecomparator signals indicating the absence of solution and a leak withinthe drape container. The NAND gate output is connected to thenon-inverting input of comparator 166, while the comparator invertinginput is connected to a reference voltage (e.g., 5V DC). The comparatorprovides a low level logic signal in response to a low NAND gate outputin order to illuminate yellow diode 149. The yellow diode is disposedbetween circuit board pins 4 and 7 with a resistor 170 (e.g., 1K Ohm)connected between pin 4 and the comparator output. A low level logicsignal produced by comparator 166 provides a sufficient voltagedifferential to enable pin 7 connected to a supply voltage (e.g., 12VDC) to illuminate yellow diode 149. Conversely, when a leak or solutionis present within the drape container, comparators 184, 186 providesignals that enable NAND gate 164 to produce a high level logic signal.Comparator 166 generates a high level logic signal in response to thehigh level NAND gate output, thereby preventing illumination of yellowdiode 149 when a leak or solution is present within the drape container.

[0057] The condition circuit basically controls system operation inresponse to detected drape container conditions. The circuit is arrangedto enable signals from comparators 184, 186 to selectively facilitate aparticular action (e.g., illuminate the red diode and speaker, enablethe green diode and heater, or illuminate the yellow diode) in responseto the occurrence of corresponding conditions for that action. In otherwords, a particular action is initiated by the condition circuit inresponse to the occurrence of corresponding conditions, while remainingactions are disabled. Thus, the green diode and heater are enabled bythe condition circuit in response to the presence of solution without aleak in the drape container, and are disabled during occurrence of otherdrape container conditions (e.g., a leak or no solution within the drapecontainer). Enablement and disablement of the yellow diode and red diodeand speaker are facilitated in a similar manner with respect to theircorresponding conditions. The condition circuit and/or circuit board mayfurther include circuitry to record the time and/or date when the systemor heater is enabled and disabled or any other information. The storedinformation may be retrieved for hospital records or to assist inevaluating system performance.

[0058] The manner in which the condition circuit operates is described,by way of example only, with reference to FIGS. 5-6. Initially, whensolution is absent from the drape container, no current flow existsbetween the drape electrodes and the voltage applied to pins 1 and 2 ofcircuit board 52 is maintained at a supplied voltage (e.g., twelve andzero volts, respectively). These conditions are similarly present whenthe drape is disconnected from or incompatible with the system. Theoutput of comparators 184 and 186 are high (e.g., indicating no leak andno solution), thereby enabling logic circuitry 190 to illuminate yellowdiode 149 as described above, while the heater, speaker and green andred diodes are disabled as described above.

[0059] In the event that solution is present without a leak in the drapecontainer, a conductive path is formed between the drape electrodes and,hence, between pins 1 and 2 of the circuit board. Since the conductivepath has a low resistance relative to resistors 191 and 193, theseresistors basically form a voltage divider with resistor 191 connectedto the supply voltage (e.g., 12V DC) and resistor 193 connected toground. The voltage divider provides each pin 1 and 2 with anintermediate voltage (e.g., approximately 7.2 V DC). Accordingly, theoutput of comparator 184 is high (e.g., indicating no leak), while theoutput of comparator 186 is low (e.g., indicating the presence ofsolution), thereby enabling logic circuitry 188 to illuminate the greendiode and actuate the power switch to enable the heater, while thespeaker and red and yellow diodes are disabled as described above.

[0060] A leak within the drape container forms a conductive path betweenthe drape electrodes (e.g., and, hence, pins 1 and 2) and ground. Thus,the potential of pin 1 is reduced below the comparator referencepotential (e.g., 5V DC), thereby causing comparator 184 to produce a lowlevel logic signal. Diode 195 provides feedback to maintain the state ofthe leak condition until power is disabled. The low output of comparator184 is inverted by inverter 194, thereby actuating oscillator 198. Theoscillator illuminates red diode 151 and actuates speaker 197 to providean audio leak indication, while the heater and green and yellow diodesare disabled as described above. The output of comparator 186 has nobearing on leak detection and is ignored with respect to actuation ofthe oscillator. The condition circuit basically generates signals tocontrol the heater and provides visual and audio indications to inform auser of the drape container status.

[0061] The condition circuitry may employ any conventional or othercomponents with any desired electrical properties (e.g., resistance,capacitance, etc.) that can perform the above-described functions. Thereference voltages utilized by comparators 184, 186 to detect drapecontainer conditions may be any suitable voltages. By way of exampleonly, the reference voltages utilized by those comparators and/or thecomponent electrical properties in the condition circuit may be derivedfrom the properties of the solutions employed. Further, the referencevoltages and/or electrical properties may be adjusted to account forobjects placed in the basin. For example, placement of conductiveobjects (e.g., instruments, etc.) within the basin may establish a pathfor current flow between the conductive segments irrespective of thepresence of solution, thereby enabling the condition circuit to indicateerroneous conditions. Accordingly, the reference voltages may beadjusted to differentiate between current flow initiated by solution andthe current flow initiated by a conductive object. Alternatively,conductive objects may be utilized in combination with a stand disposedwithin the basin to elevate the objects above the conductive segmentsand basin floor in a manner similar to that disclosed in U.S. Pat. No.6,087,636 (Faries, Jr. et al.).

[0062] In addition, the control circuitry may include devices tomeasure, record and/or provide a report (e.g., hardcopy or electronicform) of system conditions (e.g., time, date, temperature, leakindication, etc.). The report provides medical personnel documentationfor their files on the heating characteristics. The primary informationproduced is the start date and start time of solution heating, the timeinterval the solution was heated and the temperature the solutionattained during heating (e.g., partial or complete history of time andsolution temperature). The report may further include a variety ofinformation (e.g., facility name and location, patient information,doctor information, type of procedure, type of solution and/orinstruments being heated, amount of solution being heated, etc.).Referring back to FIG. 5, the control circuitry may further include aprocessor 110, a printer 120 and a communications module 180. Thesecomponents may be implemented by any conventional or other componentsperforming the functions described herein. Processor 110 is coupled totemperature controller 38 and detection circuitry 100 in order toreceive information relating to the basin, liquid temperature, heatertemperature and/or drape container conditions. The processor may receiveany additional information (e.g., facility information, doctorinformation, patient information, solution information, instrumentinformation, etc.) from medical personnel or users via processor inputdevices (not shown).

[0063] The processor further maintains the date, elapsed heating timeand occurrence time of an event or condition (e.g., the time when a leakoccurs, the time when instruments are inserted within the drapecontainer, etc.). The processor may measure the elapsed time or recordan occurrence time based on signals received from the temperaturecontroller and/or detection circuitry. For example, the processor mayinitiate measurement of a time interval in response to the detectioncircuitry indicating solution within the drape container, and may storethe elapsed and/or occurrence time in response to a leak or othercondition. The processor may further measure elapsed time or recordelapsed and/or occurrence time in response to medical personnel manuallyentering information on the processor input devices (e.g., start andstop keys). The processor collects the appropriate information andarranges the information into a report. The report may be arranged inany fashion and include any desired information. Moreover, the reportand/or information may be stored in a database or memory device (e.g.,local memory, removable memory, card, disk, etc.) for later retrieval.In addition, the processor is coupled to a processor or system display35 to display the elapsed (or running) time, report or any desiredinformation to medical personnel. The information displayed may beselected via the processor input devices, or the display may includedisplay controls (e.g., buttons, keys, etc.). Display 35 may be disposedon the cabinet (FIG. 1) at any desired location.

[0064] The processor is further coupled to printer 120 andcommunications module 180 in order to provide information to a user. Theprinter basically provides a report in hardcopy form. The processor maycontrol the printer to produce the report at specified times (e.g.,termination of heating, at particular times of day, after a particularquantity of uses, etc.) or in response to requests from medicalpersonnel via processor input devices (e.g., print key). The printer mayprint the report on any desired hardcopy medium. Preferably, the printerplaces the information onto a label that is attached to a medical file.The information may be printed during or after the solution heating, orbe stored on a memory device and printed at a desired time as describedabove. The printer may further provide additional copies of the reportin response to user requests, or a medium automatically creatingduplicates may be utilized (e.g., carbon-less paper, etc.). Cabinet 31may include a slot (not shown) to provide the printed report to a user.However, the slot may be defined at any desired location. Since thecabinet is under the drape adjacent the non-sterile drape side (e.g.,the cabinet is non-sterile), the printed report is typically retrievedfrom the cabinet after completion of the medical procedure (e.g., whenthe drape is discarded) to preserve sterility.

[0065] Communications module 180 enables the report to be provided inelectronic form. This module basically facilitates communication withother devices for transference or downloading of the report to thosedevices. For example, the information may be downloaded or transmittedover a network or other communications medium to another device (e.g.,PDA, computer, another thermal treatment system, etc.) for viewing,storage and/or printing. Moreover, the communications module mayfacilitate retrieval of information (e.g., patient information, facilityinformation, doctor information, solution information, instrumentinformation, etc.) from a database or other source for the report.

[0066] Operation of the thermal treatment system with the presentinvention drape is described with reference to FIGS. 1-5. Initially,drape 17 is placed over the top surface of the thermal treatment systemand disposed in basin 33 to form a drape receptacle. Electrode strip 95of the drape is coupled to wiring housing 45 to connect the drape to thedetection circuitry to facilitate detection of drape containerconditions. Power switch 37 is actuated and the detection circuitrysenses no voltage change across the electrodes, thereby indicating theabsence of solution and a leak within the drape container (e.g., theabsence of an electrical path between the electrodes) as describedabove. A corresponding diode may be illuminated to indicate thiscondition, while thermal treatment of the basin may be disabled.

[0067] A sterile medium is disposed within the drape receptacle and adesired temperature for the medium is entered into the system by theuser via controller 38. The sterile medium forms a conductive pathbetween the electrodes that affects the voltage across the electrodes asdescribed above. The detection circuitry senses the voltage changeindicating the presence of solution without a leak in the drapecontainer, and may illuminate a corresponding diode. Temperaturecontroller 38 subsequently controls thermal treatment of the basin.

[0068] When a leak occurs within the drape container, an electrical pathis formed between the electrodes and the basin serving as ground,thereby affecting the voltage between the electrodes as described above.The detection circuitry senses the voltage change indicating a leakwithin the drape container and may disable thermal treatment of thebasin. A corresponding diode may be illuminated to indicate thiscondition. Further, processor 110 may receive information from thetemperature controller and/or detection circuitry to record the elapsedand/or occurrence time as described above.

[0069] Processor 110 may receive appropriate information for a reportfrom the temperature controller, detection circuitry and/or processorinput devices at any time (e.g., before, during or after the heatingsession). The processor arranges the information into a desired reportas described above. The report may be produced by printer 120 ortransmitted to another device via communications module 180 as describedabove. The report may be generated in response to termination of asession (e.g., indicated by signals received by processor 110 from thetemperature controller and/or detection circuitry) or a request bymedical personnel (e.g., via processor or other input devices).

[0070] It is to be understood that the present invention may be employedfor thermal treatment systems including a plurality of basins thateither heat or cool the sterile medium. An exemplary plural basin systemand corresponding drape according to the present invention areillustrated in FIG. 8. Specifically, the plural basin system includes anintegral assembly 51 including warming basin 33 and a substantiallycircular cooling basin 56 to thermally treat sterile liquid. The systemincludes power switches 37, 57 and controllers 38, 58 to controloperation of the warming and cooling basins, respectively. The assemblyfurther houses the heating and refrigeration devices and controlcircuitry (not shown) for the individual basins to thermally treat thosebasins and liquid contained therein as described above.

[0071] A drape 55, substantially similar to drape 17 described above, isplaced over the system and within each basin to form a drape receptacletherein as described above. Sensing devices 90 are affixed atappropriate locations on the drape in the manner described above forinsertion within a corresponding basin to detect drape containerconditions within that basin. Electrode signals are conveyed from eachsensing device disposed within a basin to a corresponding individualcondition circuit associated with that basin to determine drapecontainer conditions and provide signals to control the basin insubstantially the same manner described above. The assembly may furtherinclude a wiring housing 45 associated with each basin to receiveconnector 91 of the associated sensing device and transfer signalsbetween that housing and a corresponding individual condition circuit insubstantially the same manner described above. Each wiring housingtypically includes diodes 147, 149, 151 to indicate drape containerconditions within a corresponding basin and a receptacle 49 to receive acorresponding connector 91 as described above. The individual basinseach basically function in substantially the same manner as the singlebasin system described above, where the plural basins may beindividually controlled or collectively controlled (e.g., all basinsenabled or disabled) in response to drape container conditions.

[0072] It will be appreciated that the embodiments described above andillustrated in the drawings represent only a few of the many ways ofimplementing a surgical drape with conductor and method of detectingfluid and leaks in thermal treatment system basins.

[0073] The warming, cooling and plural basin systems and theircorresponding cabinets, assemblies or housings may be of any shape orsize and may be constructed of any suitable materials. The plural basinsystem may include any quantity of heating and/or cooling basins in anycombinations. The basins of the systems may be of any shape or size, maybe constructed of any suitable thermal conducting materials (e.g.,stainless steel, etc.) and may be disposed at any suitable locations onor within the housings. The systems may include any conventional orother heating and/or refrigeration units to thermally treat the sterilemedium or other substance to any desired temperature. The heating unitmay include any conventional or other heating device and components tocontrol heating of a basin to any desired temperature (e.g., preferablyto temperatures near (e.g., above, at or below) body temperature, suchas temperatures in the approximate range of 60° F.-160° F). The heatermay be of any quantity (e.g., at least one), shape or size, and mayinclude any configuration (e.g., strips, bars, segments, etc.) thatcovers the entirety or any portion of a basin. The heater may beattached to a basin via any conventional or other fastening techniques(e.g., any type of adhesives, brackets, etc.). In addition, the heatermay be implemented by any conventional or other type of heater orheating element (e.g., heating coils, etc.) that may be disposed on orproximate a basin at any suitable locations.

[0074] The cooling unit may include any conventional or other cooling orrefrigeration device and components to control cooling of a basin to anydesired temperature (e.g., preferably to temperatures near or below thefreezing temperature of the sterile liquid or medium, such astemperatures in the approximate range of −32° F. to 32° F.). The variouspower switches and controllers of the systems may be implemented by anyconventional or other power and control devices and may be disposed onthe systems at any suitable locations.

[0075] The temperature sensor may be implemented by any quantity of anyconventional or other temperature sensing device (e.g., infrared, RTD,etc.), may be disposed at any location on, within or proximate a basinor within the systems to measure temperature of any desired items (e.g.,basin, heater or cooler, liquid, etc.). The measured item temperaturesmay be utilized for display, reports, system operational control or anyother desired application. The basins of the systems may be disposed inany arrangement or at any suitable locations on the systems. The systemsmay thermally treat (e.g., heat or cool) any type of medium or liquid,while a cooling basin may further include any type of conventional orother dislodgement mechanism, such as those described in theaforementioned patents.

[0076] The wiring housing may be of any quantity, shape or size, may beconstructed of any suitable materials, and may be disposed at anysuitable locations on the systems. The wiring housing and/or systems mayinclude any suitable conductors or other medium (e.g., wireless,fiberoptics, etc.) to transfer signals between system components. Thewiring housing may include any quantity of any type of receptacledisposed at any suitable location on the wiring housing or systems tointerface the drape. The wiring housing may include any quantity of anytype of indicator (e.g., audio, speech synthesis, LED, display screenwith text or images, speaker, etc.) to indicate the drape containerstatus. The indicator may be disposed on the wiring housing or systemsat any suitable locations. The diodes may be of any quantity or color,may be disposed at any suitable locations on the wiring housing orsystems and may be illuminated in any desired fashion or pattern (e.g.,flashing, continuous illumination, etc.). A drape container or othercondition may be associated with any quantity of any diodes of any color(e.g., the same or different colors in any desired combinations, etc.).

[0077] The drape may be of any size or shape, and may be constructed ofany suitable materials. The drape is preferably transparent ortranslucent to facilitate manipulation of controls through the drape,however, the drapes may have any degree of transparency (e.g., includingopaque). The drape may be manipulated in any fashion with any portionsof the drape serving as a drape receptacle within a corresponding basin.The drape may be of sufficient size to accommodate and form drapereceptacles within any quantity of thermal treatment system basins.

[0078] The sensing device may include any quantity of electrodes orelectrode strips disposed at any suitable locations on a drape. Theelectrodes may be constructed of any suitable conductive materials. Theelectrode strip may be of any shape or size, and may be constructed ofany suitable materials. The electrodes may be fastened to the strip atany suitable locations via any conventional or other fasteningtechniques. The pouch may be of any quantity, shape or size, may beconstructed of any suitable materials, may contain any portions of theelectrodes or electrode strip and may be fastened to the drape at anysuitable locations via any conventional or other fastening techniques.The flap may be of any quantity, shape or size, may be attached to thedrape at any suitable locations via any conventional or other fasteningtechniques to form the pouch and may be constructed of any suitablematerials. The seams may be disposed on the flap at any suitablelocations to attach the flap to the drape to form the pouch. The flapmay include any quantity of openings or slots of any shape or sizedisposed in any suitable locations on the flap or pouch and arranged inany fashion to enable liquid within the drape container to contact theelectrodes. Alternatively, the sensing device or electrode strip may beattached to the drape (e.g., without the pouch) via patches or any othersecuring mechanisms (e.g., adhesives, welding, etc.) to sense drapecontainer conditions.

[0079] The drape opening may be of any quantity, shape or size and maybe defined in the drape at any suitable locations (e.g., drape portionswithin the basin, on the top surface, near the controller or wiringhousing, along the cabinet side walls, etc.). The patches may be of anyquantity, shape or size, may be constructed of any suitable materialsand may be disposed at any suitable locations on the drape. The drapemay include any quantity of openings and corresponding patches disposedon or attached to either or both of the sterile and non-sterile drapesurfaces. Any patch portions may be attached to the drape, where thebend or fold may be disposed at any location and the transverse patchsections may extend at any angle or orientation. Alternatively, thepatches may lay flat against the drape with the strip extending throughthe patches or from a peripheral patch edge. Further, any quantity ofpatches may be utilized to seal the opening and/or strip, where thepatches may be disposed at any locations relative to the drape opening(e.g., same or opposing sides, any angular displacement, etc.) and beattached to each other and/or the drape.

[0080] The patches may be secured or attached to any portions of eachother, any portions of the strip and/or any portions of the drape (e.g.,at any locations, the entirety or any portion thereof, etc.) via anyconventional or other techniques (e.g., adhesives, heat welding,pressure, etc.). The drape may include any quantity of sensing devicesfor a corresponding basin where the sensing device signals may becombined in any fashion (e.g., at least one device detecting liquid,combined logically (e.g., AND, OR, etc.), etc.) to determine occurrenceof drape container conditions (e.g., solution or leaks present). Thesensing device plug may be implemented by any conventional or other plugor connector where the electrode traces may be disposed at any locationson the plug. Alternatively, the electrode strip or other objects maytraverse a drape peripheral or other edge (e.g., without being disposedthrough the drape) to extend between the sterile and non-sterile drapesurfaces.

[0081] Drape container conditions may be determined based on any desiredelectrical or other parameters or characteristics (e.g., potential orvoltage, current, resistance, etc.) of any quantity of electrodes. Theparameters may be measured at any suitable locations (e.g., at anylocations along each electrode, between the electrodes, between theelectrodes and basin, at the basin, between the electrodes and detectioncircuitry, within the detection circuitry, etc.). In addition, thepresence of the drape may be detected based on the connection (or lackthereof) of the drape electrodes to the thermal treatment system (ordetection circuitry) to control system operation (e.g., disable thermaltreatment of the basin in the absence of a drape).

[0082] The control circuit may be disposed within the systems at anysuitable locations and may be implemented by any conventional or othercircuitry components arranged in any desired fashion to perform thedescribed functions. The systems may be powered by any conventional orother power source (e.g., AC, DC, wall outlet jack, batteries, etc.).The plugs connecting the power supply or other components may beimplemented by any conventional or other connectors for transferringsignals. The power cord may be implemented by any conventional or othercord or cable and be configured to accommodate any desired powersignals. The thermostat may be implemented by any conventional switchingtype or limiting devices, such as a high limit thermostat, and may bedisposed at any suitable location within the systems.

[0083] The detection circuitry may be disposed within the system at anysuitable locations and may include any quantity of conventional or othercomponents arranged in any desired fashion to perform the functionsdescribed herein. The detection circuitry may utilize any suitablereference potentials to detect solution, leaks or any other conditions.The electrical connections may include any quantity of components (e.g.,power cord, fuses, conductors, connectors, power supply, circuit board,diodes, etc.) arranged in any desired fashion, where each component maybe implemented by any conventional or other component performing thedescribed function. The temperature controller may be implemented by anyconventional or other temperature controller and include any desireddevices for entering a temperature (e.g., buttons, keypad, etc.). Thetemperature controller may control the heater to any desired temperaturerange, and may utilize any quantity of set points (e.g., maximum and/orminimum, etc.). The basin power switches of the systems may beimplemented by any conventional or other switching device, while thefuses may be implemented by any conventional fuse or other limitingdevice and may be configured for any current or voltage levels.

[0084] The circuit board housing the condition circuit may include anyquantity of terminals or pins each associated with any desired signalsor portion of the condition circuit. The circuit board may include anyquantity of indicators disposed at any suitable locations to indicatethe occurrence or status of any desired circuit portion or condition.The power supply may be implemented by any conventional or other powersupply or source and provide any desired power signals, and may includeany type of conventional or other receptacle for receiving any type ofplug or connector. The diodes or other indicators may be connected tothe circuit board pins in any desired fashion. The circuit board mayhouse the condition circuit and/or any other desired system circuitry.Further, the circuit board may include devices to record any types ofinformation relating to system operation for subsequent retrieval andanalysis (e.g., date and time of thermal treatment disablement andenablement, etc.).

[0085] The condition circuit may include any quantity of conventional orother components arranged in any desired fashion to perform thefunctions described herein. The circuit comparators may be implementedby any conventional or other comparators or comparing devices and mayutilize any suitable reference potentials to detect solution, leaks orany other conditions. The inverters may be implemented by anyconventional or other inverting devices (e.g., logic gates, circuitry,etc.) to invert circuit signals. The logic circuitry and correspondinglogic gates may be implemented by any logic gates or combinational logic(e.g., AND, OR, NAND, NOR, XOR, etc.) and/or circuitry (e.g.,comparator, inverter, transistors, etc.) arranged in any desired fashionto combine signals to determine the occurrence of any conditions. Thelogic circuitry comparators may be implemented by any conventional orother comparators or comparing devices and utilize any desired referencepotentials. The oscillator may be implemented by any conventional orother timer or oscillating device producing outputs at any desiredfrequency. The oscillator may drive any type of device (e.g., speaker,speech synthesis, diode, etc.) to indicate the presence of a condition,while the indicator devices may alternatively be driven by any type ofcircuitry or mechanism. The speaker may be implemented by anyconventional or other speaker or audio device and may provide anysuitable audio indication (e.g., beep at any suitable periodic interval,continuous audio output, etc.).

[0086] The triac may be implemented by any conventional or other triacor relay type device to provide signals to thermal control circuitry forcontrolling thermal treatment of a basin. The condition circuit mayinclude any conventional or other circuitry (e.g., resistors,capacitors, inductors, diodes, supply and ground potentials, etc.)arranged in any fashion and including any desired electricalcharacteristic values (e.g., resistance, potential, capacitance, etc.)to facilitate circuit operation. The condition circuit signals mayinclude any desired logic or voltage levels. The optocoupler may beimplemented by any conventional or other optocoupler or other circuitryto control the triac to provide signals to the thermal controlcircuitry.

[0087] The plural basin system may include individual thermal controland detection circuitry associated with each basin to monitor drapecontainer conditions and control basin operation. Alternatively, theplural basin system may include common thermal control and detectioncircuitry to control each basin in response to drape containerconditions. The common circuitry may receive signals from each of theelectrodes and control the basins individually or collectively inresponse to the drape container conditions. The common circuitry mayprocess and combine the signals in any fashion (e.g., AND, OR, etc.) todetermine conditions for controlling the basins.

[0088] The detection circuitry of the systems may alternatively includea microprocessor to process electrode signals and control theindicators, heater or any other devices. In this case, electrode signalsare converted to digital signals and compared by the microprocessor tothreshold levels for each condition. The microprocessor may generate theappropriate control signals to control basin thermal devices and variousindicators in accordance with the determined conditions. Themicroprocessor may be implemented by or implement the temperaturecontroller and/or report processor.

[0089] The control circuitry may include devices to record any types ofinformation relating to system operation for subsequent retrieval,analysis, display and reports (e.g., date and time of thermal treatmentdisablement and enablement, etc.). The processor may be implemented byany conventional or other microprocessor or controller and include anyquantity of any desired input devices (e.g., buttons, keypad, etc.). Theprocessor may maintain the date, elapsed heating time and/or occurrencetime of any event or condition (e.g., time when a leak occurs, timeinstruments inserted within drape container, etc.). The processor maymeasure the elapsed time or record an occurrence time for any desiredcondition. The processor may maintain the time information internally orutilize any desired external circuitry (e.g., a timer, etc.).

[0090] The processor may collect any desired information (e.g., startdate and time of solution heating, the time interval the solution washeated, the temperature the solution attained during heating, partial orcomplete history of time and solution temperature measured at anydesired time intervals, facility name and location, patient information,doctor information, type of procedure, type of solution and/orinstruments being heated, amount of solution being heated, etc.) fromany desired sources (e.g., detection circuitry, temperature controller,user, memory device, another computer or device, etc.).

[0091] The reports may be arranged in any fashion and include anydesired information. The report information may be arranged and/orpresented (e.g., printed, displayed, etc.) in any desired formats (e.g.,text, charts, graphs, etc.). The report and/or information mayalternatively be stored in a local or remote database or memory device(e.g., local memory, removable memory, etc.) for later retrieval. Thereports may include a pre-arranged format or may be programmable orselected by a user via processor input devices. The system, controllerand processor displays may be of any quantity, shape or size, may bedisposed at any location on and/or within the system (e.g., cabinet,wiring housing, etc.) or remote from the system, may be implemented byany conventional or other displays (e.g., LED, LCD, etc.) and maydisplay any desired information. The information displayed may beselected via controller or processor input devices, or the display mayinclude display controls (e.g., buttons, keys, etc.).

[0092] The printer may be implemented by any conventional or otherprinting device, may be local or remote, may serve any quantity ofsystems or other devices, and may produce reports on any desired medium(e.g., paper, labels, etc.). The reports may be printed at any specifictime or in response to user entered information (e.g., a print commandor key). The printer slot may be of any quantity, shape or size and maybe disposed at any suitable location on the cabinet and/or wiringhousing. The report may be printed at any desired time before, during orafter system use, and may be retrieved from the system at any desiredtime or in any desired manner that preserves a sterile field (e.g.,after completion of the medical procedure, after discarding the drape,times when a sterile field is not needed or being employed by thesystem, etc.).

[0093] The communications module may be implemented by any conventionalor other communications device or module (e.g., modem, etc.) and maydownload or transfer an electronic form of the report to any desireddevice (e.g., PDA, computer, another thermal treatment or other system,etc.) at any specific time or in response to user entered information(e.g., transmit command or key). The systems may further be networked toenable retrieval of reports and/or information from a station coupled tothe network. The printer and communications module may be disposed atany suitable locations on or within the system (e.g., on or within thecabinet, wiring housing, etc.) or remote from the system. Any desiredinformation may be transmitted between the control circuitry components(e.g., temperature controller, detection circuitry, processor, printer,communications module, displays, etc.) via any conventional or othercommunications medium or protocols (e.g., hardwire, wireless, network,etc.). The processor may implement or be implemented by the temperaturecontroller. The temperature sensor may be coupled to the temperaturecontroller, microprocessor and/or processor either individually or inany combination or fashion.

[0094] Software for the temperature controller, detection circuitmicroprocessor for processing the electrode signals and report processormay be implemented in any desired computer language and could bedeveloped by one of ordinary skill in the computer arts based on thefunctional descriptions contained herein. The controller, microprocessorand/or processor may alternatively be implemented by any type ofhardware and/or other processing circuitry, and may be availablepre-programmed for immediate use. The various functions of thecontroller, microprocessor and/or processor may be distributed in anymanner among any quantity of software modules, processors and/orcircuitry.

[0095] It is to be understood that the terms “top”, “bottom”, “front”,“rear”, “side”, “height”, “length”, “width”, “upper”, “lower” and thelike are used herein merely to describe points of reference and do notlimit the present invention to any particular orientation orconfiguration.

[0096] The drape is not limited to the applications or systems describedabove, but may be utilized to facilitate placement of any types ofobjects (e.g., conductors, tubes or other fluid passages, variouscommunication medium, etc.) through or around the drape in any manner(e.g., traverse any drape opening or drape edge, etc.) to enablecommunication or passage (e.g., of objects, signals and/or information)between the sterile and non-sterile sides of the drape withoutcompromising the sterile field. Further, the electrodes or othercommunication medium may be connected to various sensors or any othertypes of measuring, analytical and/or control devices to measure,determine and/or indicate any types of conditions and/or control systemoperation in any desired fashion in response thereto.

[0097] From the foregoing description, it will be appreciated that theinvention makes available a novel surgical drape with conductor andmethod of detecting fluid and leaks in thermal treatment system basins,wherein a surgical drape includes a sensing device with an electrodesealed through the drape via a plurality of patches on the non-steriledrape surface to provide signals indicating drape container conditionsto a thermal treatment system to facilitate control of system operation.

[0098] Having described preferred embodiments of a new and improvedsurgical drape with conductor and method of detecting fluid and leaks inthermal treatment system basins, it is believed that othermodifications, variations and changes will be suggested to those skilledin the art in view of the teachings set forth herein. It is therefore tobe understood that all such variations, modifications and changes arebelieved to fall within the scope of the present invention as defined bythe appended claims.

What is claimed is:
 1. A system for detecting conditions withincontainers formed by surgical drapes during surgical procedures andcontrolling thermal treatment of said containers in response to saiddetected conditions, said system comprising: a thermal treatment unit tothermally treat a liquid and including a basin; a surgical drape,covering and substantially conforming to said basin, to serve as a drapecontainer for said liquid; a sensing device including a plurality ofconductors each disposed on a sterile drape surface within said drapecontainer and extending therefrom through said drape to a non-steriledrape surface, wherein said conductors are secured to said drape via aplurality of material segments disposed on said non-sterile drapesurface, and wherein potentials of said conductors are responsive tocontact between said conductors and said liquid and indicate conditionsof said drape container; a controller to operate said thermal treatmentunit to control a temperature of said basin; and a detection unit incommunication with said drape to determine occurrence of said drapecontainer conditions from said potentials of said conductors and tocontrol said controller to operate said thermal treatment unit inaccordance with said determined drape container conditions.
 2. Thesystem of claim 1, wherein said plurality of conductors includes aplurality of electrodes.
 3. The system of claim 1, wherein said drapeincludes an opening defined therein to permit passage of said pluralityof conductors therethrough and said material segments are attached tosaid drape non-sterile surface proximate said opening to seal saidopening.
 4. The system of claim 3, wherein said plurality of materialsegments encompass said opening with a first portion of each materialsegment attached to said drape non-sterile surface and second portionsof said material segments attached to each other to seal said opening.5. The system of claim 4, wherein each material segment includes a foldbetween said first and second portions.
 6. The system of claim 4,wherein said second portion of each material segment extendstransversely relative to said first portion of that material segment andsaid drape non-sterile surface.
 7. The system of claim 4, wherein saidplurality of conductors are disposed through said opening and betweensaid plurality of material segments.
 8. The system of claim 1 furtherincluding a plurality of indicators to indicate drape containerconditions, wherein said indicators are actuable in response to controlsignals generated by said detection unit in accordance with saiddetermined occurrence of said drape container conditions.
 9. The systemof claim 8, wherein at least one indicator includes a visual indicatorto visually indicate occurrence of a drape container condition.
 10. Thesystem of claim 8, wherein at least one indicator includes an audioindicator to produce audio signals to indicate occurrence of a drapecontainer condition.
 11. The system of claim 1, wherein said detectionunit disables said thermal treatment unit in response to determining thepresence of a leak or absence of said liquid within said drapecontainer.
 12. The system of claim 1, wherein said detection unitenables said thermal treatment unit in response to determining thepresence of said liquid and absence of a leak within said drapecontainer.
 13. The system of claim 1, wherein said drape detects andfacilitates indication of conditions of said drape container includingthe presence of said liquid and a leak within said drape container. 14.The system of claim 1, wherein said thermal treatment unit is operativeto cool said liquid in said drape container.
 15. The system of claim 1,wherein said thermal treatment unit is operative to heat said liquid insaid drape container.
 16. The system of claim 1, wherein said drapeincludes a pre-formed container portion to form said drape containerwithin said basin.
 17. The system of claim 1 further including aprocessor to collect information relating to said liquid and to generatea report including said collected information.
 18. The system of claim17 further including a printer to print a hardcopy of said report. 19.The system of claim 17 further including a communications module toestablish communications and transfer information with another device.20. The system of claim 19, wherein said processor generates said reportin electronic form and said communications module transmits said reportto said other device.
 21. The system of claim 1 further including: aplurality of said thermal treatment units to thermally treat said liquidand each including a basin, wherein said surgical drape covers andsubstantially conforms to each said basin to serve as said drapecontainer for said liquid in each said basin; a plurality of saidsensing devices each including a plurality of said conductors disposedon said sterile drape surface within a corresponding drape container andextending therefrom to a non-sterile drape surface; at least onecontroller to operate said thermal treatment units to controltemperature of each said basin; and at least one detection unit incommunication with each said sensing device to determine occurrence ofdrape container conditions within said each basin from said potentialsof said conductors associated with that basin to control said at leastone controller to operate said thermal treatment units in accordancewith said determined drape container conditions.
 22. A device fordetecting conditions within a basin of a thermal treatment system duringsurgical procedures and facilitating control of thermal treatment ofsaid basin and liquid contained therein in response to said detectedconditions, said device comprising: a surgical drape to cover andsubstantially conform to said basin to serve as a drape container forsaid liquid; and a sensing device including a plurality of conductorseach disposed on a sterile drape surface within said drape container andextending therefrom through said drape to a non-sterile drape surface,wherein said conductors are secured to said drape via a plurality ofmaterial segments disposed on said non-sterile drape surface, andwherein potentials of said conductors are responsive to contact betweensaid conductors and said liquid and indicate conditions of said drapecontainer.
 23. The device of claim 22, wherein said plurality ofconductors includes a plurality of electrodes.
 24. The device of claim22, wherein said drape includes an opening defined therein to permitpassage of said plurality of conductors therethrough and said materialsegments are attached to said drape non-sterile surface proximate saidopening to seal said opening.
 25. The device of claim 24, wherein saidplurality of material segments encompass said opening with a firstportion of each material segment attached to said drape non-sterilesurface and second portions of said material segments attached to eachother to seal said opening.
 26. The device of claim 25, wherein eachmaterial segment includes a fold between said first and second portions.27. The device of claim 25, wherein said second portion of each materialsegment extends transversely relative to said first portion of thatmaterial segment and said drape non-sterile surface.
 28. The device ofclaim 25, wherein said plurality of conductors are disposed through saidopening and between said plurality of material segments.
 29. The deviceof claim 22, wherein said drape includes a pre-formed container portionto form said drape container within said basin.
 30. The device of claim22, wherein said sensing device detects and facilitates indication ofconditions of said drape container including the presence of said liquidand a leak within said drape container.
 31. A method of detectingconditions during surgical procedures within a container formed within athermal treatment system basin by a surgical drape to contain liquid andcontrolling thermal treatment of said drape container in response tosaid detected conditions, said method comprising: (a) placing saidsurgical drape over said thermal treatment system to cover andsubstantially conform to said basin to serve as a drape container forsaid liquid, wherein said drape includes a sensing device with aplurality of conductors disposed on a sterile drape surface within saiddrape container and extending therefrom through said drape to anon-sterile drape surface, and wherein said conductors are secured tosaid drape via a plurality of material segments disposed on saidnon-sterile drape surface; (b) altering potentials of said conductors inresponse to contact between said conductors and said liquid to indicateconditions of said drape container; and (c) determining occurrence ofsaid drape container conditions from said potentials of said conductorsand controlling said thermal treatment system to thermally treat saidbasin in accordance with said determined drape container conditions. 32.The method of claim 31 wherein said plurality of conductors includes aplurality of electrodes, and step (b) further includes: (b.1) alteringpotentials of said electrodes in response to contact between saidelectrodes and said liquid to indicate conditions of said drapecontainer.
 33. The method of claim 31, wherein step (c) furtherincludes: (c.1) detecting and facilitating indication of said drapecontainer conditions including the presence of said liquid and a leakwithin said drape container.
 34. The method of claim 31, wherein step(c) further includes: (c.1) actuating at least one of a visual and anaudio indicator to indicate said determined occurrence of said drapecontainer conditions.
 35. The method of claim 31, wherein step (c)further includes: (c.1) disabling said thermal treatment system inresponse to determining the presence of a leak or absence of said liquidwithin said drape container.
 36. The method of claim 31, wherein step(c) further includes: (c.1) enabling said thermal treatment system inresponse to determining the presence of said liquid and absence of aleak within said drape container.
 37. The method of claim 31 furtherincluding: (d) collecting information relating to said liquid andgenerating a report including said collected information.
 38. The methodof claim 37 further including: (e) printing a hardcopy of said report.39. The method of claim 37 further including: (e) establishingcommunications and transferring information with another device.
 40. Themethod of claim 39, wherein step (e) further includes: (e.1) generatingsaid report in electronic form and transmitting said report to saidother device.
 41. The method of claim 31 wherein said thermal treatmentsystem includes a plurality of said basins, and step (a) furtherincludes: (a.1) placing said surgical drape over said thermal treatmentsystem to cover and substantially conform to each said basin to serve asa drape container for said liquid, wherein said surgical drape includesa plurality of said sensing devices each including a plurality of saidconductors disposed on said sterile drape surface within a correspondingdrape container and extending therefrom to said non-sterile drapesurface; step (b) further includes: (b.1) altering potentials of saidconductors of a corresponding drape container in response to contactbetween those conductors and said liquid to indicate conditions of thatdrape container; and step (c) further includes: (c.1) determiningoccurrence of conditions of each said drape container from saidpotentials of said conductors associated with that drape container andcontrolling said thermal treatment system to thermally treat said basinsin accordance with said determined drape container conditions.
 42. Amethod of detecting conditions within a basin of a thermal treatmentsystem during surgical procedures and facilitating control of thermaltreatment of said basin and liquid contained therein in response to saiddetected conditions, said method comprising: (a) forming a surgicaldrape to cover and substantially conform to said basin to serve as adrape container for said liquid; (b) disposing a sensing deviceincluding a plurality of conductors on a drape portion serving as saiddrape container with said conductors disposed on a sterile drape surfacewithin said drape container and extending therefrom through said drapeto a non-sterile drape surface, wherein said conductors are secured tosaid drape via a plurality of material segments disposed on saidnon-sterile drape surface, and wherein potentials of said conductors areresponsive to contact between said conductors and said liquid andindicate conditions of said drape container.
 43. The method of claim 42,wherein said plurality of conductors includes a plurality of electrodes,and step (b) further includes: (b.1) disposing said electrodes on saidsterile drape surface within said drape container, wherein saidelectrodes extend between sterile and non-sterile drape surfaces. 44.The method of claim 42, wherein step (b) further includes: (b.1)defining an opening within said drape to permit passage of saidplurality of conductors therethrough; and (b.2) attaching said materialsegments to said drape non-sterile surface proximate said opening toseal said opening.
 45. The method of claim 44, wherein step (b.2)further includes: (b.2.1) attaching said material segments to said drapenon-sterile surface to encompass said opening with a first portion ofeach material segment attached to said drape non-sterile surface andsecond portions of said material segments attached to each other to sealsaid opening.
 46. The method of claim 45, wherein each material segmentincludes a fold between said first and second portions.
 47. The methodof claim 45, wherein step (b.2.1) further includes: (b.2.1.1) attachingsaid material segments to said drape non-sterile surface with saidsecond portion of each material segment extending transversely relativeto said first portion of that material segment and said drapenon-sterile surface.
 48. The method of claim 45, wherein step (b)further includes: (b.3) disposing said plurality of conductors throughsaid opening and between said plurality of material segments.
 49. Themethod of claim 42, wherein step (a) further includes: (a. 1) formingsaid drape to include a pre-formed container portion to form said drapecontainer within said basin.
 50. The method of claim 42, wherein step(b) further includes: (b.1) disposing said conductors on said steriledrape surface within said drape container, wherein said potentials ofsaid conductors indicate conditions of said drape container includingthe presence of said liquid and a leak within said drape container.